Imaging of Cannabinoid 1 Receptors Using [11C]OMAR and PET

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Marc Potenza, Yale University
ClinicalTrials.gov Identifier:
NCT01719497
First received: October 29, 2012
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

The aim of the present study is to conduct a human trial of [C-11]OMAR, a new PET imaging agent for the brain cannabinoid type 1 receptors (CB1), to determine its pharmacokinetics and binding characteristics.


Condition Intervention
Obesity
Alcohol Dependence
High Stress
Drug: [C-11]OMAR

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Imaging of Cannabinoid 1 Receptors Using [11C]OMAR and PET

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • No outcome measures for this study, this is an imaging study only [ Time Frame: Upon study completion ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: June 2009
Estimated Study Completion Date: June 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Alcohol
Subjects diagnosed with alcohol dependence
Drug: [C-11]OMAR
PET radioligand
Obese
Subjects diagnosed with obesity
Drug: [C-11]OMAR
PET radioligand
High Stress
Subjects diagnosed with high stress
Drug: [C-11]OMAR
PET radioligand
Healthy
Subjects deemed medically healthy
Drug: [C-11]OMAR
PET radioligand

Detailed Description:

This is a pilot, 2-part study to assess the kinetics of radioactivity in medically healthy subjects, subjects with alcohol dependency (AD), and obese subjects following the intravenous administration of the imaging agent [C-11]OMAR.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

N = 30 Medically Healthy control subjects N = 30 Subjects with high stress exposure N = 30 Subjects with Alcohol Dependence (AD) N = 30 Obese subjects

Criteria

Inclusion Criteria:

  1. Are overtly healthy males or females (other than AD or obesity), as determined by medical history and physical examination. Males and females with stable medical problems that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the subject at increased risk by participating in the study, and will not interfere with interpretation of the data.
  2. Are between the ages of 18 and 65 years, inclusive.
  3. Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator. (Note: specific laboratory tests are listed in section 3.4)
  4. Have arterial access sufficient to allow blood sampling as per the protocol.
  5. Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
  6. Have given written informed consent approved by the ethical review board governing the site.

Exclusion Criteria:

  1. Are currently enrolled in, or discontinued within the last [30 days] from, a clinical trial involving an off-label use of an investigational drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
  2. Current substance abuse (other than AD) including marijuana use, or severe systemic disease based on history and physical exam.
  3. Laboratory tests with clinically significant abnormalities or positive urine toxicology screen. (Note: specific laboratory tests are listed in section 3.4)
  4. Prior participation in other research protocols in the last year such that radiation exposure would exceed the annual limits.
  5. Presence of ferromagnetic metal in the body or heart pacemaker.
  6. Are persons who have previously completed or withdrawn from this study or any other study investigating [C-11]OMAR.
  7. Regularly use known drugs of abuse (other than alcohol) within 30 days of the study and/or show positive findings on urinary drug screening.
  8. Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies.
  9. Are women with a positive pregnancy test or women who are lactating.
  10. Have a history of head trauma with prolonged loss of consciousness (>10 minutes), or any neurological condition including stroke or seizure (excluding a single childhood febrile seizure) or a history of migraine headaches
  11. History of adverse drug reactions or intolerance to more than three types of systemically administered medications
  12. Have used any prescription medication (except for oral contraceptives or hormone replacement therapy) or over-the-counter medication (including herbal remedies or diet aids) within 14 days of the imaging session. Multiple vitamins are specifically permitted
  13. Have implanted or embedded metal objects or fragments in the head or body that would present a risk during the MRI scanning procedure, or have worked with ferrous metals either as a vocation or hobby (for example, as a sheet metal worker, welder, or machinist) in such a way that might have led to unknown, indwelling metal fragments that could cause injury if they moved in response to placement in the magnetic field
  14. Have had exposure to ionizing radiation that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719497

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Marc N Potenza, MD, PhD Yale University
  More Information

No publications provided

Responsible Party: Marc Potenza, Professor of Psychiatry, Child Study, and Neurobiology, Yale University
ClinicalTrials.gov Identifier: NCT01719497     History of Changes
Other Study ID Numbers: 0906005296
Study First Received: October 29, 2012
Last Updated: March 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alcoholism
Obesity
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014